Safety and Clinical Performance of the Freesolve Resorbable Magnesium Scaffold System

Exclusion Criteria30

• Subject is hemodynamically stable with documented declining cardiac biomarkers;
• Target lesion(s) to be treated are not located in the culprit vessel(s) and are not culprit lesion(s)
• Subject is eligible for Dual Antiplatelet Therapy (DAPT) with aspirin plus either clopidogrel, prasugrel, ticagrelor or ticlopidine
• Documented left ventricular ejection fraction (LVEF) ≥ 30% within 6 months prior to or during the procedure (prior to randomization)
• Subject is willing and able to comply with protocol requirements, including completion of study visits for the duration of the study
• Subject is pregnant and/or breastfeeding or intends to become pregnant during the duration of the study
• Subject has clinical symptoms and/or electrocardiogram (ECG) changes consistent with STEMI \< 72 hours prior to the index procedure.
• Note: Hemodynamically stable non-STEMI (NSTEMI) subjects are eligible for study enrollment.
• Subject has undergone prior PCI within the target vessel during the last 12 months prior to the index procedure or prior PCI within a non-target vessel \<72 hours prior to the index procedure if successful and uncomplicated
• Subject is on dialysis or with impaired renal function (serum creatinine \> 2.5 mg/dL or 221 µmol/L, determined within 72 hours prior to the index procedure)
• Subject has a known allergy to contrast medium that cannot be adequately premedicated, or any known allergy to aspirin, P2Y12 inhibitors, both heparin and bivalirudin, sirolimus, everolimus (or similar limus drugs), poly L-lactide, the scaffold material (magnesium, aluminium, tantalum), or Xience stent material (cobalt, chromium, tungsten, nickel, -methacrylic polymer, and fluoropolymer)
• Subject is receiving oral or intravenous immunosuppressive therapy (inhaled steroids are permitted) or has known life-limiting immunosuppressive or autoimmune disease (e.g., human immunodeficiency virus, systemic lupus erythematosus; diabetes mellitus is permitted)
• Life expectancy less than 1 year
• Planned surgery or dental surgical procedure within 6 months after index procedure, unless DAPT can be maintained
• In the investigator's opinion subject will not be able to comply with the follow-up requirements
• Subjects under oral anticoagulation therapy (OAC) prior to index procedure unless DAPT + OAC (i.e. triple therapy) can be maintained for a minimum of 1 month
• Subject has had a stroke or transient ischemic attack (TIA) within 6 months prior to the index procedure
• Subject with active bleeding disorder, active coagulopathy, or any other reason, who is ineligible for DAPT
• Subject is currently participating or plans to participate in another study with an investigational device or an investigational drug
• Target vessel has been previously treated and the target lesion is within 5 mm proximal or distal to the previously treated lesion
• Left main coronary artery disease
• Target lesion was totally occluded (100% stenosis)
• Thrombus in target vessel
• Future planned staged PCI either in target or non-target vessel
• Ostial target lesion within the left descending (LAD), left circumflex (LCx), or right coronary artery (within 5.0 mm of vessel origin)
• Target lesion involves a side branch ≥ 2.0 mm in diameter that requires a two-device strategy after pre-dilatation
• Target lesion is located in or supplied by an arterial or venous bypass graft
• The target lesion requires treatment with the device other than the non-compliant balloon and/or cutting/scoring balloon prior to scaffold/stent placement (including but not limited to atherectomy devices, intravascular lithotripsy, drug-coated balloons etc.)
• Target vessel was treated with brachytherapy any time prior to the index procedure.
• Unsuccessful pre-dilatation, defined as residual stenosis \> 20% (by visual estimation) and / or angiographic complications (e.g. distal embolization, side branch closure, flow-limiting dissections)